- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03753984
Effects of Low-level Laser Therapy in the Fatigue Muscle of Healthy Individual and Spastic Individuals
July 12, 2019 updated by: Universidade do Vale do Paraíba
Analysis of the Effects of Low-level Laser Therapy in the Muscular Fadiga of the Braquial Biceps Muscle of Healthy Individual and Spastic Individuals
Muscle fatigue is caused by biochemical changes that modify the mechanics of muscle contraction, which result in negative changes in the performance of the contraction.
The objective of this study is to evaluate the effects of LLLT on brachial biceps muscle fatigue in healthy individuals and individuals with spastic hemiparesis.
The study will consist of three groups (Control Group, Placebo Group and LLLT Group) and all individuals will go through all groups, following the criteria of randomization.
The protocol consists of LLLT application in the dominant side brachialis muscle in healthy subjects and on the hemiparetic side of post-stroke individuals, prior to performing the Isometric Maximum Voluntary Contraction (IMVC) for 50 seconds in the isokinetic dynamometer.
Will be evaluated pain, myoelectric activity associated with muscular torque, local temperature and blood lactate concentration.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Muscle fatigue is caused by biochemical changes that modify the mechanics of muscle contraction, which result in negative changes in the performance of the contraction.
Several resources are studied in order to mitigate this situation, among them we can mention the Low Level-Laser Therapy (LLLT), which has demonstrated positive effects in the treatment of muscle disorders and fatigue prevention.
The effects of LLLT are being studied in healthy individuals with fibromyalgia and athletes, currently studies are being performed on spastic muscles with post-stroke patients (post-stroke).
The objective of this study is to evaluate the effects of LLLT on brachial biceps muscle fatigue in healthy individuals and individuals with spastic hemiparesis.
A double-blind, cross-sectional, comparative, randomized, double-blind clinical trial will be conducted.
Phase I will consist of 30 healthy individuals and Phase II will be composed of 30 post-stroke individuals.
The study will consist of three groups (Control Group, Placebo Group and LLLT Group) and all individuals will go through all groups, following the criteria of randomization.
The protocol consists of LLLT application in the dominant side brachialis muscle in healthy subjects and on the hemiparetic side of post-stroke individuals, prior to performing the Isometric Maximum Voluntary Contraction (IMVC) for 50 seconds in the isokinetic dynamometer.
The pain intensity will be evaluated through the Visual Analog Pain Scale, the myoelectric activity through the surface electromyography associated with the evaluation of the muscular torque through the isokinetic dynamometer.
The local temperature will be evaluated by infrared thermography and blood lactate concentration by means of the lactimeter, which will be measured at four different times, prior to the application of the laser (basal collection) and 3, 15 and 25 minutes after IMVC.
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Gabriela S Souza
- Phone Number: 5512997232806
- Email: gabrielasouza507@yahoo.com.br
Study Contact Backup
- Name: Gabriela S Souza
- Phone Number: 5512997232806
- Email: fpupio@univap.br
Study Locations
-
-
São Paulo
-
São José Dos Campos, São Paulo, Brazil, 12.244-000
- Recruiting
- Universidade do Vale do Paraíba
-
Contact:
- Gabriela S Souza
- Phone Number: 5512997232806
- Email: gabrielasouza507@yahoo.com.br
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria (Healthy group):
- Preserved cognition, and preservation of the ability to respond to verbal stimul;
- To present the "insufficient active" or "active" indices on the scale of the International Questionnaire of Physical Activity.
Inclusion Criteria (Post stroke group):
- Individuals with medical diagnosis of stroke;
- Individuals with physiotherapeutic diagnosis of spastic hemiparesis with brachial predominance;
- Preserved cognition and preservation of the ability to respond to verbal stimuli;
- Injury time: after 12 months;
- Patients with a maximum of 2 degree spasticity according to the Modified Ashworth Scale and minimum muscle strength of 1 in the biceps brachii muscle.
Exclusion Criteria (Healthy group):
- Possess musculoskeletal impairment of the dominant upper limb;
- Practice physical activity with load (bodybuilding);
- Presence of active infection and eruptions in the dominant upper limb;
- Limiting pain that makes it impossible to perform the evaluation protocol;
- Ingestion of analgesic and / or anti-inflammatory drugs and / or drugs containing corticosteroids or steroids.
- Fitzpatrick classification: Phototypes V and VI;
- Presence of malignant neoplastic lesion;
- Presence of active infection and eruptions at the electrode application site;
- Hypoesthesia and / or hyperesthesia and / or anesthesia of the limb in which TLBI will be applied.
Exclusion Criteria (Healthy group):
- Presence of active infection and eruptions in the dominant upper limb;
- Limiting pain that makes it impossible to perform the evaluation protocol;
- Ingestion of analgesic and / or anti-inflammatory drugs and / or drugs containing corticosteroids or steroids.
- Fitzpatrick classification: Phototypes V and VI;
- Presence of malignant neoplastic lesion;
- Presence of active infection and eruptions at the electrode application site;
- Hypoesthesia and / or hyperesthesia and / or anesthesia of the limb to be treated;
- Muscular contractures and joint deformities;
- Uncontrolled arterial hypertension;
- Individuals with other associated neurological and / or orthopedic disorders;
- Wernick or Broca's aphasia.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Healthy group
The protocol consists of Low-level laser therapy (LLLT) application in the dominant side brachialis muscle in healthy subjects prior to performing the Isometric Maximum Voluntary Contraction (IMVC) for 50 seconds in the isokinetic dynamometer and will be analize Visual Analog Pain Scale, electromyography associated with the evaluation of the muscular torque through the isokinetic dynamometer, local infrared thermography and blood lactate concentration by means of the lactimeter, which will be measured at four different times, prior to the application of the laser (basal collection) and 3, 15 and 25 minutes after IMVC.
All the participants will pass for three groups: Control group (not will be applicate LLLT), Placebo group (laser will be off) and LLLT group (will be applicate LLLT).
|
In both arms will be applied Low-level laser therapy and induced muscle fatigue.
|
EXPERIMENTAL: Post stroke group
The protocol consists of Low-level laser therapy (LLLT) application in the hemiparetic side brachialis muscle post stroke individuals prior to performing the Isometric Maximum Voluntary Contraction (IMVC) for 50 seconds in the isokinetic dynamometer and will be analize Visual Analog Pain Scale, surface electromyography with the evaluation of the muscular torque through the isokinetic dynamometer, local infrared thermography and blood lactate concentration, which will be measured at four different times, prior to the application of the laser (basal collection) and 3, 15 and 25 minutes after IMVC.
All the participants will pass for three groups: Control group (not will be applicate LLLT), Placebo group (laser will be off) and LLLT group (will be applicate LLLT).
|
In both arms will be applied Low-level laser therapy and induced muscle fatigue.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in pain sensation
Time Frame: Baseline (before test) and will be assessed from the beginning to the end of the test (50 seconds).
|
To analize the pain.
The scale is composed of a horizontal line with a scale of 0 to 10, with 0 representing no pain and 10 representing the worst possible pain.
|
Baseline (before test) and will be assessed from the beginning to the end of the test (50 seconds).
|
Surface electromyograph
Time Frame: Will be assessed from the beginning to the end of the test (50 seconds).
|
To analize the myoelectric activity.
The surface electrodes will be placed in pairs on the muscular belly of the biceps and triceps brachii muscles, following the longitudinal direction of the muscle fibers.
|
Will be assessed from the beginning to the end of the test (50 seconds).
|
Analyze the behavior of the local temperature (Infra-red thermography)
Time Frame: Baseline (Before test) and will be assessed from the beginning to the end of the test (50 seconds).
|
To analize the local temperature.
|
Baseline (Before test) and will be assessed from the beginning to the end of the test (50 seconds).
|
To evaluate changes in lactate concentration through lactimeter.
Time Frame: Baseline (before test) and after the test (3, 15 and 25 minutes after the test)
|
A collection of blood lactate levels will be performed at four different times.
|
Baseline (before test) and after the test (3, 15 and 25 minutes after the test)
|
Isokinetic dynamometer
Time Frame: Will be assessed from the beginning to the end of the test (50 seconds).
|
To analize muscle torque
|
Will be assessed from the beginning to the end of the test (50 seconds).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Fernanda P Lima, Doctor, Universidade do Vale do Paraíba
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 1, 2018
Primary Completion (ACTUAL)
June 1, 2019
Study Completion (ANTICIPATED)
March 1, 2020
Study Registration Dates
First Submitted
October 31, 2018
First Submitted That Met QC Criteria
November 23, 2018
First Posted (ACTUAL)
November 27, 2018
Study Record Updates
Last Update Posted (ACTUAL)
July 15, 2019
Last Update Submitted That Met QC Criteria
July 12, 2019
Last Verified
November 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UNIVAP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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